New rules for diagnostic products, but who will certify them? “An extreme shortage area”

In less than two weeks, new and stricter EU rules will enter into force for thousands of products used in important diagnoses of, among other things, cancer and Covid-19. However, not one single institute in the entire Nordic region is able to certify

Lucy Robertshaw: Are we in the perfect storm?

“Is there a perfect storm on the horizon again as elective surgeries were cancelled due to patients being admitted with Covid-19? We now have a long backlog of people who are presenting with chronic diseases that need to access healthcare again”, writes Lucy Robertshaw in a column.

Marie Gårdmark: Finally, it’s time for a revision of the EU pharma legislation

A challenge for the EU Commission is to deliver a new framework that will also take care of another “pillar” of the pharmaceutical strategy, namely, to ensure that new medicines will be available for all citizens in Europe, writes Marie Gårdmark in a column.

Lundbeck behind the first EU-approved intravenous migraine treatment

A preventive, intravenous treatment for migraines has been approved in the EU for the first time.

The route to vaccines for everyone: “We did not just sit around and wait”

The pandemic was in full swing, and no one knew when or even if a vaccine would come. At that point, the Swedish Minister of Social Affairs called with a proposal, and Richard Bergström did not hesitate. “I already had a notion that this would work,” he says in an interview with Life Science Sweden.

Giulia Gaudenzi: Innovation for good

"I challenge the innovator landscape to take a mental leap. Relying on innovation-solely to end inequality is not enough, therefore consciously and purposively – we need to engage bravely with the politics of poverty and scarcity. Even in life sciences", writes Giulia Gaudenzi in a column.

Efter positiva resultat för Valneva: ”Ansökan till EMA skickas så snart som möjligt”

Efter att ha stoppats av Storbritannien ser det nu ljusare ut för Valnevas covid-19-vaccinkandidat sedan positiva fas III-resultat presenterats. Nu väntar ansökan till EMA. "Det behövs mer vaccin eftersom hela världen ska få tillgång till vaccin och kunna vaccinera sig", säger Valnevas Sverige-chef Janet Hoogstraate.

Sweden and Denmark – this is how they choose their strategies

Scandinavia’s two major powers in pharmaceutical research have developed strategies for growth in life science, and both countries aim to become world leaders.

ATMP-expert till Eliceras styrelse

Karin Hoogendoorn har valts in i styrelsen för Elicera Therapeutics.

Marie Gårdmark: Big data evidence generation drives change in the EU regulatory system

Rapid developments in technology have led to the possibility for the generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? In a column Marie Gårdmark, CEO and Senior Consultant at RegSmart Life Science, develops her views on this subject.

Column: Repurposing as a golden ticket to approval

"Hopefully, in the end, patients will be winners by receiving on-label treatments for which benefit-risk has been properly assessed." In a column Marie Gårdmark, CEO at RegSmart Life Science, reflects on drug repurposing.

SDS Life Science satsar på regulatorisk spetskompetens

New diagnostic test soon ready for the market

Storbritannien godkänner Pfizers covid-19 vaccin

Vaccinet kommer att finnas tillgängligt på brittiska sjukhus från och med början på nästa vecka.

Läkemedelsupptäckt med CRISPR-screening

Marie Gårdmark: Do EMA and FDA talk to each other?

Of course they do! The collaboration started already in 2003, writes Marie Gårdmark in a column.

Abigo nyanställer

Life science-företaget Abigo har anställt en ny kommunikationschef och en ny risk and quality specialist.

Här är vaccinkandidaterna mot coronaviruset

Totalt finns det idag tio pågående kliniska studier om vaccinkandidater mot det nya coronaviruset.

Giulia Gaudenzi: ”Key lessons from global health research”

The world will still face major challenges in the post Covid-19 pandemic, writes Giulia Gaudenzi at the KTH Division of Nanobiotechnology at Scilifelab, in a column.

Nya chefer på Xvivo

Anne-Li Sigvardsson och Andreas Wallinder rekryteras inifrån bolaget.

Pilots want to live too

Drug development creates new challenges for regulators

Krönika: Can regulators keep up with innovation?

New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market

Engage with your CMO early

Gordon Hutton is Materials Science Lead at Thermo Fisher Scientific’s, formerly GSK, small molecule API site in Cork, Ireland.